NMPA vs INVIMA: Medical Device Regulatory Comparison
Compare the medical device registration pathways, classification, and regulatory requirements of NMPA (China) vs INVIMA (Colombia).
NMPA
National Medical Products Administration (China)
China
China's NMPA regulates medical devices through CMDE (Center for Medical Device Evaluation) technical reviews. China uses a three-class risk-based system. Foreign manufacturers must appoint a Marketing…
Class I, II, III
NMPA Registration (CMDE review)
- ▸CMDE technical review
- ▸MAH (Marketing Authorization Holder) system
- ▸In-country testing requirements
- ▸Clinical trial oversight
- ▸NMPA registration certificates
INVIMA
INVIMA — Colombia Medical Device Regulatory Authority
Colombia
INVIMA is the national regulatory authority responsible for medical device oversight in Colombia. It manages device registration, market surveillance, and adverse event reporting within the Latin Amer…
Class I, IIa, IIb, III
INVIMA registration
- ▸Device registration
- ▸Market surveillance
- ▸Adverse event reporting
- ▸Import/export control
MedFlux monitors both NMPA and INVIMA in real time — every regulatory change, safety alert, and market signal delivered in under 90 seconds.
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